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Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol

5 czerwca 2026 zaktualizowane przez: Anna Bach Pascual, Hospital del Mar

Longitudinal Tracking of Physical Frailty and Health-Related Quality of Life Through Patient-Reported Outcome Measures in Adult Candidates on the Kidney Transplant Waiting List

This study looks at how the physical and emotional health of people changes while they wait for a kidney transplant. Waiting for an organ can take a long time. During this period, some patients become "frail." This means they lose strength and are at a higher risk for health problems.

The main goal is to follow these patients over time to better understand their needs. Researchers will use a mobile application to collect Patient-Reported Outcome Measures (PROMs) directly from patients about how they feel and their quality of life. The study will also include personal interviews to learn about the patients' experiences and any difficulties they face when using technology.

The results of this study will help to: • Identify early which patients are losing strength or health. • Improve the support that nurses provide during the transplant waiting period. • Make sure that digital health tools are easy for everyone to use.

In short, this work aims to help patients reach the day of their surgery in the best possible condition.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Study Design and Framework This research employs a convergent-parallel mixed-methods design to evaluate frailty dynamics and patient-reported outcomes in Kidney Transplantation (KT) candidates. The quantitative component is a longitudinal observational study, while the qualitative component is grounded in Heideggerian hermeneutic phenomenology to explore the lived experience of patients during the waiting list period.

Quantitative Procedures and Data Collection Participants will be recruited during their initial KT evaluation at Hospital del Mar (Barcelona). Frailty will be assessed using the Fried Phenotype (assessing weight loss, exhaustion, physical activity, walk time, and grip strength) at baseline and subsequently every six months while the patient remains on the waiting list.

To monitor Patient-Reported Outcome Measures (PROMs), the study utilizes the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.0 questionnaire. This instrument covers seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles/activities, and pain interference. Data collection will be performed via a digital platform (electronic PROMs [ePROMs]), allowing for real-time monitoring. For patients facing technological or language barriers, an Advanced Practice Nurse (APN) will provide support to ensure data completeness and minimize selection bias.

Qualitative Exploration A purposive sample of participants will undergo in-depth semi-structured interviews. These sessions will focus on the subjective meaning of frailty, the impact of the waiting period on daily life, and the experience of using digital health tools. Interviews will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis to identify core existential themes.

Quality Assurance and Data Management • Data Validation: A data dictionary has been developed, defining each variable, its source, and acceptable ranges to ensure consistency. • Source Data Verification: Data entered into the electronic Case Report Form (eCRF) will be cross-referenced with electronic medical records to ensure accuracy. • Standard Operating Procedures (SOPs): Specific SOPs are in place for patient recruitment, the standardized administration of physical performance tests (e.g., handgrip strength using a dynamometer), and the management of technical issues with the ePROM platform.

Statistical Analysis Plan (SAP) Quantitative data will be analyzed using SPSS (Statistical Package for the Social Sciences, v.25). Descriptive statistics will summarize baseline characteristics. Longitudinal changes in frailty scores and PROMs will be analyzed using linear mixed models or Generalized Estimating Equations (GEE) to account for repeated measures. The relationship between frailty status and PROMs will be assessed using correlation coefficients and multivariate regression models adjusted for age, comorbidity, and time on dialysis.

Missing Data Plan The study aims to minimize missing data through APN-led follow-up. If data are missing at random, multiple imputation techniques will be considered. For patients unable to use digital tools, paper-based alternatives or assisted entry will be provided to reduce non-response bias.

Sample Size Assessment The sample size is based on the prevailing activity of the kidney transplant unit, aiming to include all eligible candidates over the recruitment period (estimated N ≈ 150-200) to ensure sufficient power for detecting longitudinal changes in frailty prevalence and its association with PROMs.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

150

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Anna Bach Pascual, RN, MSN i PhDc
  • Numer telefonu: +34 648653656
  • E-mail: abach@hmar.cat

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

The study population consists of adult patients with End-Stage Renal Disease (ESRD), also classified as Stage 5 chronic kidney disease, managed at the Nephrology Department of Hospital del Mar (Barcelona). This clinical cohort includes patients currently receiving renal replacement therapy (either maintenance haemodialysis or peritoneal dialysis) as well as individuals in the pre-dialysis stage who have been formally referred for comprehensive kidney transplant evaluation. The target population is characterized by a high burden of medical comorbidity and varying degrees of physical frailty associated with chronic uraemia and long-term dialysis treatment.

Opis

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Diagnosed with Stage 5 chronic kidney disease (CKD).
  • Currently undergoing clinical evaluation for or actively listed on the deceased-donor kidney transplant waiting list at Hospital del Mar (Barcelona).
  • Cognitive and physical ability to understand and provide written informed consent.
  • Ability to use or have regular access to a digital device (smartphone or tablet) for electronic Patient-Reported Outcome Measures (ePROMs) completion.

Exclusion Criteria:

  • Severe cognitive impairment or active psychiatric disorders that prevent the reliable completion of questionnaires or physical tests.
  • Major physical disability that precludes the objective assessment of gait speed or handgrip strength (e.g., bilateral lower limb amputation or severe dominant hand deformity).
  • Acute medical illness requiring hospitalization at the time of enrolment.
  • Total language barrier that prevents understanding the study components or the qualitative interview.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Kidney Transplant Candidates

This is a single-group observational cohort of adult patients with Stage 5 Chronic Kidney Disease (CKD) undergoing evaluation or active on the deceased-donor kidney transplant waiting list. All participants undergo a longitudinal follow-up every six months to monitor frailty dynamics and health perceptions.

Data collection includes:

  • Physical assessments: Evaluation using the Fried Phenotype framework (measuring handgrip strength and gait speed).
  • Patient-Reported Outcome Measures (PROMs): Assessment via the digital platform for the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 (electronic PROMs [ePROMs]).
  • Qualitative exploration: Hermeneutic interviews for a selected subset to explore the lived experience of frailty.

No clinical intervention or medication will be administered.
Inny: Longitudinal Frailty Assessment

Systematic multidimensional assessment of physical frailty conducted by an Advanced Practice Nurse (APN) specialized in nephrology.

The evaluation encompasses the following components:

  • Fried Phenotype: Objective measurement of 5 criteria: unintended weight loss, self-reported exhaustion, physical activity level, gait speed (over 4 meters), and handgrip strength (using a calibrated hydraulic dynamometer).
  • Clinical Frailty Scale (CFS): Global clinical judgment score based on the patient's overall fitness and functional independence.
  • Short Physical Performance Battery (SPPB): Standardized test battery to objectively assess balance, gait speed, and lower limb strength through timed chair stands.

Frequency: Assessments will be performed at baseline and every 6 months (+/- 1 month) throughout the patient's presence on the kidney transplant waiting list. Standardized protocols ensure data reproducibility.

Inne nazwy:
  • Fried Frailty Phenotype Assessment
  • Physical Performance Monitoring
  • Comprehensive Frailty Evaluation
  • Clinical Frailty Scale (CFS)
Inny: Electronic Patient-Reported Outcome Measures (ePROMs)

Implementation of a digital health strategy to monitor patient-reported outcomes throughout the kidney transplant waiting list period.

Core Instrument: Participants complete the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 v2.0 questionnaire, assessing 7 health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles/activities, pain interference, and pain intensity.

Procedure: • Data Collection: Administered via a secure electronic Patient-Reported Outcome Measures (ePROMs) digital platform accessible via smartphone, tablet, or computer. • Frequency: Data collected at baseline and every 6 months, coinciding with physical frailty assessments. • Support: An Advanced Practice Nurse (APN) provides technical onboarding and follows up on non-compliance to address the digital divide.

This observational strategy aims to capture the patient's subjective health status.

Inne nazwy:
  • PROMIS-29 v2.0 Questionnaire
  • Digital Health Monitoring
  • Patient-Reported Quality of Life Assessment

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in Frailty Status (Fried Phenotype)
Ramy czasowe: Baseline, 6 months, 12 months

Change in frailty status over time assessed using the Fried Frailty Phenotype cumulative score, with a total score ranging from 0 to 5 points, where higher scores indicate greater physical frailty.

Frailty status categories are defined as:

Non-frail: 0 points Pre-frail: 1-2 points Frail: 3-5 points

The outcome measure will assess longitudinal changes in the cumulative frailty score and frailty category during the patient's time on the kidney transplant waiting list.
Baseline, 6 months, 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Patient-Reported Outcome Measures (PROMs)
Ramy czasowe: Baseline, 6 months, 12 months

Change over time in health-related quality of life measured using the Patient-Reported Outcomes Measurement Information System-29 version 2.0 (PROMIS-29 v2.0).

PROMIS-29 domain scores are reported as standardized T-scores ranging from approximately 20 to 80, where 50 represents the population mean and 10 the standard deviation.

Higher scores indicate more of the concept being measured:

Higher physical function and social participation scores indicate better functioning.

Higher anxiety, depression, fatigue, sleep disturbance, and pain interference scores indicate worse symptoms.

Each PROMIS domain score will be analyzed independently according to PROMIS scoring guidelines.
Baseline, 6 months, 12 months
Incidence of Clinical Transitions on the Waiting List
Ramy czasowe: 12 Months
Incidence and time-to-event of major clinical transitions affecting transplant waiting list status, including kidney transplantation, temporary or permanent removal from the waiting list, and all-cause mortality.
12 Months
Digital Tool Usability and Implementation Barriers
Ramy czasowe: 12 months

Assessment of the feasibility and usability of the electronic Patient-Reported Outcome Measures (ePROMs) platform during longitudinal follow-up.

Feasibility will be evaluated using questionnaire completion and adherence rates across the study period. Implementation barriers related to technology use and digital access will be identified and categorized through qualitative documentation obtained during Advanced Practice Nurse (APN) follow-up sessions.
12 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hospital del Mar

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2028

Ukończenie studiów (Szacowany)

1 lipca 2028

Daty rejestracji na studia

Pierwszy przesłany

19 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 maja 2026

Pierwszy wysłany (Rzeczywisty)

26 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2024/11603

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data (IPD) will not be shared at this time to protect the confidentiality of the participants and the integrity of the ongoing doctoral thesis. The data collected involves sensitive clinical information and qualitative interviews within a specific, small-scale clinical setting (kidney transplant waiting list).

However, the study results will be disseminated through peer-reviewed publications and conference presentations. Requests for access to aggregate data or specific methodological details can be directed to the Principal Investigator and will be considered on a case-by-case basis, subject to approval by the Institutional Review Board (CEIm) and in compliance with the General Data Protection Regulation (GDPR)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Jakość życia

Badania kliniczne na Longitudinal Frailty Assessment

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